Cervical CarcinomaNCT03372720
Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors
A study testing Laser Therapy and Questionnaire Administration in people with Cervical Carcinoma and Dyspareunia, run by Ohio State University Comprehensive Cancer Center at 4 sites in United States.
Trial summary
This randomized pilot trial studies how well fractional carbon dioxide (CO2) laser therapy works in minimizing genitourinary syndrome of menopause (GSM) in gynecological cancer survivors. Fractional CO2 laser therapy may reduce symptoms of GSM in survivors of gynecologic cancers. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Carcinoma, Dyspareunia, Endometrial Carcinoma
- What is being tested?
- Laser Therapy and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 May 2018to 12 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women with cervical, endometrial, vaginal, vulvar or ovarian cancer who have completed all cancer related treatment >= 6 months prior to enrollment
- Any form of hysterectomy, including radical hysterectomy permitted
- Must have no evidence of recurrent disease on pelvic exam within past 3 months
- Radiation therapy is permitted but not required
- Patient reported dyspareunia and/or vaginal dryness with severity of >= 4 on a scale from 0 (none) to 10 (most severe) that has been persistent over >= 4 weeks and/or the inability to be sexually active due to pain
Who cannot join
- Patients with recurrent or metastatic endometrial, vaginal, vulvar, cervical, or ovarian cancer
- Pelvic organ prolapse stage II or higher
- Prior reconstructive pelvic surgery involving mesh
- Hormone replacement therapy or vaginal estrogen therapy within 6 weeks prior to enrollment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58104
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Fractional CO2 Laser Therapy for Survivors of Gynecologic Malignancies
This randomized pilot trial studies how well fractional carbon dioxide (CO2) laser therapy works in minimizing genitourinary syndrome of menopause (GSM) in gynecological cancer survivors. Fractional CO2 laser therapy may reduce symptoms of GSM in survivors of gynecologic cancers.
Read the detailed description
PRIMARY OBJECTIVES:
- To conduct a pilot trial to estimate the proportion of gynecologic cancer patients with vaginal dryness or dyspareunia, who will have an improvement in their symptoms with vaginal laser therapy compared to sham treatment based on the Vaginal Assessment Scale (VAS).
SECONDARY OBJECTIVES:
- To evaluate toxicity associated with vaginal laser therapy in this population.
II. To determine how many women with the defined patient eligibility will complete all treatments.
III. To determine the feasibility of the crossover design for potential use in a phase III trial.
IV. To determine improvement in objective findings of vaginal atrophy with vaginal laser therapy versus sham treatment.
- To determine improvement in sexual function as measured by Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS), and scales for sexual satisfaction and behavior with vaginal laser therapy versus sham treatment.
VI. To determine improvement in urinary symptoms of urogenital atrophy with vaginal laser therapy versus sham treatment using the Urogenital Distress Inventory (UDI).
VII. To demonstrate satisfaction with vaginal fractional CO2 laser therapy.
OUTLINE: Patients are randomized in to 1 of 2 arms.
ARM I: Patients undergo fractional CO2 laser therapy at 3 time points 30 days apart.
ARM II: Patients undergo sham laser therapy at 3 time points 30 days apart. Patients may then crossover to Arm I.
After completion of study, patients are followed up at 1 month.
- Conditions
- Cervical Carcinoma, Dyspareunia, Endometrial Carcinoma, Ovarian Carcinoma, Vaginal Carcinoma, Vaginal Dryness
- Being tested
- Laser Therapy, Questionnaire Administration, Sham Intervention
- Medical subject headings
- Uterine Cervical Neoplasms, Dyspareunia, Endometrial Neoplasms, Ovarian Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser TherapyProcedure or surgery
Also called Therapy, Laser
Undergo fractional CO2 laser therapy
Questionnaire AdministrationOther
Ancillary studies
Sham InterventionProcedure or surgery
Undergo sham laser therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm I (fractional CO2 laser therapy) | Experimental | Patients undergo fractional CO2 laser therapy at 3 time points 30 days apart. Receives: Procedure: Laser Therapy; Other: Questionnaire Administration |
| Arm II (sham laser therapy) | Sham comparator | Patients undergo sham laser therapy at 3 time points 30 days apart. Patients may then crossover to Arm I. Receives: Other: Questionnaire Administration; Procedure: Sham Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in genitourinary syndrome of menopause (GSM) symptoms
Will be assessed by the Vaginal Assessment Scale (VAS). Will be summarized and compared between the treatment arms using a two-sample t-test or a Wilcoxon rank sum test, with a two-sided alternative for each. Will also analyze this endpoint graphically by plotting the VAS scores through time by treatment arm. Additionally, will correlate the scores from the VAS with other validated measures using a Spearman's correlation coefficient in an exploratory manner.
Measured: Baseline to 12 weeks
Secondary outcomes (8)
Feasibility as measured by number of patients able to complete 3 study visitis
A crossover design to determine the feasibility of the crossover design for potential use in a phase III trial by summarizing the proportion of patients who are unable to tolerate the study treatment prior to completing the 3 treatments
Measured: Up to 1 month
Improvement in objective findings of vaginal atrophy
Will determine improvement in objective findings of vaginal atrophy with vaginal laser therapy versus sham treatment.
Measured: Up to 1 month
Improvement in sexual function by FSFI
Will determine improvement in sexual function as measured by Female Sexual Function Index (FSFI)
Measured: Up to 1 year
Improvement in sexual function FSDS
Will determine improvement in sexual function as measured by Female Sexual Distress Scale-Revised (FSDS)
Measured: Up to 1 year
Improvement in urinary symptoms
Will determine improvement in urinary symptoms of urogenital atrophy with vaginal laser therapy versus sham treatment using the Urogenital Distress Inventory (UDI). The change in dyspareunia and dryness between baseline (T0) and T4 will be calculated and compared between the treatment and sham arms using a two sample t-test or Wilcoxon rank sum test.
Measured: Up to 1 month
Incidence of adverse events
Adverse event grading will be done according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE)
Measured: Up to 1 month
Number of patients complete all treatments
Summarize the proportion of patients who are able to tolerate the study treatment and complete the 3 treatments.
Measured: Up to 1 month
Satisfaction with vaginal fractional CO2 laser therapy
Patients will be asked to rate their satisfaction with the procedure on a likert-type scale of 1-10 with 1 being completely dissatisfied and 10 being extremely satisfied. Participants will be asked to rate their satisfaction on this scale after each treatment and at follow-up.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start11 May 2018
- Primary completion18 Dec 2019
- Study completion12 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Quick, Ohio State University Comprehensive Cancer Center
- Investigators
- Allison Quick, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372720
- Sponsor's protocol ID
- OSU-17261
- Other IDs
- NCI-2017-02051
- Status last verified
- Apr 2022
- First submitted
- 13 Nov 2017
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
PubMed 40709601Quick AM, Dockter T, Le-Rademacher J, Salani R, Hudson C, Hundley A, Terstriep S, Streicher L, Faubion S, Loprinzi CL, Coleman JS, Wang KC, Lustberg M. Pilot study of fractional CO2 laser therapy for genitourinary syndrome of menopause in gynecologic cancer survivors. Maturitas. 2021 Feb;144:37-44. doi: 10.1016/j.maturitas.2020.10.018. Epub 2020 Dec 2.
PubMed 33358206
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional CO2 Laser Therapy for Survivors of Gynecologic Malignancies
- ClinicalTrials.gov ID
- NCT03372720
- Acronym / sponsor ID
- OSU-17261
- Conditions
- Cervical Carcinoma, Dyspareunia, Endometrial Carcinoma, Ovarian Carcinoma, Vaginal Carcinoma, Vaginal Dryness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 11 May 2018 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 12 Apr 2022 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized pilot trial studies how well fractional carbon dioxide (CO2) laser therapy works in minimizing genitourinary syndrome of menopause (GSM) in gynecological cancer survivors. Fractional CO2 laser therapy may reduce symptoms of GSM in survivors of gynecologic cancers.
Detailed description
PRIMARY OBJECTIVES:
- To conduct a pilot trial to estimate the proportion of gynecologic cancer patients with vaginal dryness or dyspareunia, who will have an improvement in their symptoms with vaginal laser therapy compared to sham treatment based on the Vaginal Assessment Scale (VAS).
SECONDARY OBJECTIVES:
- To evaluate toxicity associated with vaginal laser therapy in this population.
II. To determine how many women with the defined patient eligibility will complete all treatments.
III. To determine the feasibility of the crossover design for potential use in a phase III trial.
IV. To determine improvement in objective findings of vaginal atrophy with vaginal laser therapy versus sham treatment.
- To determine improvement in sexual function as measured by Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS), and scales for sexual satisfaction and behavior with vaginal laser therapy versus sham treatment.
VI. To determine improvement in urinary symptoms of urogenital atrophy with vaginal laser therapy versus sham treatment using the Urogenital Distress Inventory (UDI).
VII. To demonstrate satisfaction with vaginal fractional CO2 laser therapy.
OUTLINE: Patients are randomized in to 1 of 2 arms.
ARM I: Patients undergo fractional CO2 laser therapy at 3 time points 30 days apart.
ARM II: Patients undergo sham laser therapy at 3 time points 30 days apart. Patients may then crossover to Arm I.
After completion of study, patients are followed up at 1 month.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (fractional CO2 laser therapy) | Experimental | Procedure: Laser Therapy, Other: Questionnaire AdministrationPatients undergo fractional CO2 laser therapy at 3 time points 30 days apart. |
| Arm II (sham laser therapy) | Sham comparator | Other: Questionnaire Administration, Procedure: Sham InterventionPatients undergo sham laser therapy at 3 time points 30 days apart. Patients may then crossover to Arm I. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Women with cervical, endometrial, vaginal, vulvar or ovarian cancer who have completed all cancer related treatment >= 6 months prior to enrollment
- Patient reported dyspareunia and/or vaginal dryness with severity of >= 4 on a scale from 0 (none) to 10 (most severe) that has been persistent over >= 4 weeks and/or the inability to be sexually active due to pain
Key exclusion criteria (4 listed)
- Patients with recurrent or metastatic endometrial, vaginal, vulvar, cervical, or ovarian cancer
- Pelvic organ prolapse stage II or higher
- Prior reconstructive pelvic surgery involving mesh
- Hormone replacement therapy or vaginal estrogen therapy within 6 weeks prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser TherapyAlso: Therapy, LaserUndergo fractional CO2 laser therapy | Procedure or surgery | Arm I (fractional CO2 laser therapy) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (fractional CO2 laser therapy), Arm II (sham laser therapy) |
| Sham InterventionUndergo sham laser therapy | Procedure or surgery | Arm II (sham laser therapy) |
Primary outcome
Change in genitourinary syndrome of menopause (GSM) symptoms
Time frame: Baseline to 12 weeks
Will be assessed by the Vaginal Assessment Scale (VAS). Will be summarized and compared between the treatment arms using a two-sample t-test or a Wilcoxon rank sum test, with a two-sided alternative for each. Will also analyze this endpoint graphically by plotting the VAS scores through time by treatment arm. Additionally, will correlate the scores from the VAS with other validated measures using a Spearman's correlation coefficient in an exploratory manner.
8 secondary outcomes
Feasibility as measured by number of patients able to complete 3 study visitis
Time frame: Up to 1 month
Improvement in objective findings of vaginal atrophy
Time frame: Up to 1 month
Improvement in sexual function by FSFI
Time frame: Up to 1 year
Improvement in sexual function FSDS
Time frame: Up to 1 year
Improvement in urinary symptoms
Time frame: Up to 1 month
Incidence of adverse events
Time frame: Up to 1 month
Number of patients complete all treatments
Time frame: Up to 1 month
Satisfaction with vaginal fractional CO2 laser therapy
Time frame: Up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Derived from this study: PubMed 40709601Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
- Derived from this study: PubMed 33358206Quick AM, Dockter T, Le-Rademacher J, Salani R, Hudson C, Hundley A, Terstriep S, Streicher L, Faubion S, Loprinzi CL, Coleman JS, Wang KC, Lustberg M. Pilot study of fractional CO2 laser therapy for genitourinary syndrome of menopause in gynecologic cancer survivors. Maturitas. 2021 Feb;144:37-44. doi: 10.1016/j.maturitas.2020.10.018. Epub 2020 Dec 2.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Quick, MD principal investigator
Ohio State University Comprehensive Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Therapy and Questionnaire Administration in people with Cervical Carcinoma and Dyspareunia, run by Ohio State University Comprehensive Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in genitourinary syndrome of menopause (GSM) symptoms (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03372720, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.